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Like the Bard Biopsy Needle (K871390), the Auto Suture* ABBI* Breast Biopsy System is intended for obtaining biopsies from breast tissues for diagnostic purposes. The device is not intended for therapeutic excision of tissue.

Both the Auto Suture* ABBI* Breast Biopsy System, and Bard® Biopty® Instrument Biopty-Cut® Needle (K871390) are indicated for obtaining soft tissue samples under imaging control.

This 510(k) summary describes a manual surgical instrument and does not appear to involve an AI/ML device. Therefore, the requested information regarding acceptance criteria, study data, ground truth, and reader studies for an AI/ML device is not applicable to this submission.

The "PERFORMANCE" section in the provided document merely states that "Both the Auto Suture* ABBI* Breast Biopsy System and the Bard Biopsy Needle (K871390) are effective in removing a sample of tissue for biopsy." This is a general statement of intended function rather than a detailing of specific performance metrics or a study demonstrating their achievement.

For a medical device like this biopsy system, performance is typically demonstrated through:

• Bench testing: Verifying aspects like cutting efficiency, sample integrity, and mechanical function.
• Biocompatibility: Ensuring materials are safe for human contact (as noted with ISO Standard #109931).
• Sterility validation: Confirming the device can be sterilized effectively.
• Comparison to predicate device: Demonstrating substantial equivalence to a legally marketed device (the Bard Biopty instrument).

However, none of these are elaborated with specific acceptance criteria or study results in the provided summary as would be relevant for an AI/ML product.

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